510(k) K161176 ยท LCJ Tissue Expander And Accessories
ARTOURA Breast Tissue Expanders with Smooth Surface
| Applicant | Mentor Worldwide, LLC, Irvin CA, US |
| Decision | Substantially Equivalent, May 23, 2016 |
| Received | Apr 26, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H
Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc Open, Classified |
LCJ | None listed |
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH
Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc Open, Classified |
LCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.